Telmisartan Tablets — Class II drug recall D-0388-2024
Terminated recall by Micro Labs Limited, reported 2024-03-20, distributed in PR, RI, TN. Failed Stability Specifications: Out of specification for blend uniformity.
| Recall number | D-0388-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Labs Limited, Verna, N/A, India |
| Recall initiated | 2024-02-09 |
| Classified | 2024-03-14 |
| Reported by FDA | 2024-03-20 |
| Terminated | 2025-06-24 |
| Distributed | PR, RI, TN |
| Quantity | 118,080 bottles |
| Reason classes | specification failure |
| NDC | 42571-0227-30 |
| Lot numbers | SFBG024, SFBG025 |
| Expiration dates | 2024-05-31 |
Product
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
Reason for recall
Failed Stability Specifications: Out of specification for blend uniformity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0388-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.